EP1471855B1 - Bandscheibenprothese - Google Patents

Bandscheibenprothese Download PDF

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Publication number
EP1471855B1
EP1471855B1 EP03731993A EP03731993A EP1471855B1 EP 1471855 B1 EP1471855 B1 EP 1471855B1 EP 03731993 A EP03731993 A EP 03731993A EP 03731993 A EP03731993 A EP 03731993A EP 1471855 B1 EP1471855 B1 EP 1471855B1
Authority
EP
European Patent Office
Prior art keywords
disk prosthesis
prosthesis
intervertebral
intervertebral disk
vertebra
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP03731993A
Other languages
English (en)
French (fr)
Other versions
EP1471855A4 (de
EP1471855A2 (de
Inventor
Walter W. Eckman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Concept Matrix LLC
Original Assignee
Concept Matrix LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Concept Matrix LLC filed Critical Concept Matrix LLC
Publication of EP1471855A2 publication Critical patent/EP1471855A2/de
Publication of EP1471855A4 publication Critical patent/EP1471855A4/de
Application granted granted Critical
Publication of EP1471855B1 publication Critical patent/EP1471855B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30462—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/3049—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a slidable sleeve covering the connection
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
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    • A61F2002/30649—Ball-and-socket joints
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0071—Three-dimensional shapes spherical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/0076—Quadric-shaped ellipsoidal or ovoid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Definitions

  • the present invention relates to an apparatus for intervertebral disk replacement and more particularly to an intervertebral disk prosthesis capable of being implanted in a patient utilizing minimally invasive surgical techniques.
  • the spine 120 also known as the vertebral column or the spinal column, is a flexible column of vertebrae 100 (special types of bones) held together by muscles, ligaments and tendons.
  • the spine 120 extends from the cranium (not shown) to the coccyx 126, encasing a spinal cord 128 and forming the supporting axis of the body (not shown).
  • the spinal cord 128 is a thick bundle of nerve tissue (nerves) that branch off to various areas of the body for the purposes of motor control, sensation, and the like.
  • the spine 120 includes seven cervical vertebrae (not shown), twelve thoracic vertebrae (not shown), five lumbar vertebrae, L I - L V , five sacral vertebrae, S I - S V , and three coccyx vertebrae 126.
  • the sacral and coccyx vertebrae are each fused, thereby functioning as a single unit.
  • Fig. 10 shows the lumbar region 122, the sacral region 124 and the coccyx 126 of the spine 120 and that the vertebrae 100 are stacked one upon another.
  • the top portion 100a and bottom portion 100b of each vertebrae 100 is slightly concave.
  • the opposing concave vertebral surfaces form the intervertebral space 121 in which an intervertebral disk (not shown) resides.
  • Each of the intervertebral disks has a soft core referred to as a nucleus pulposus or nucleus (not shown).
  • each vertebrae 100 includes a body 106 in the innermost portion, a spinal canal 108 and a spinous process 102 at the posterior-most end of the vertebra 100.
  • the vertebrae 100 are substantially similar in composition, but vary in size from the larger lumbar vertebrae to the smallest coccyx vertebrae 126.
  • Each vertebrae 100 further includes two transverse processes 104 located on either side and a protective plate-like structure referred to as a lamina 110. Nerves from the spinal cord 128 pass through the spinal canal 108 and foramina 111 to reach their respective destinations within the body.
  • the natural aging process can cause a deterioration of the intervertebral disks, and therefore, their intrinsic support strength and stability is diminished. Sudden movements may cause a disk to rupture or herniate. A herniation of the disk is primarily a problem when the nucleus pulposus protrudes, bulges or ruptures into the spinal canal 108 placing pressure on nerves which in turn causes spasms, tingling, numbness, and/or pain in one or more parts of the body, depending on the nerves involved.
  • Surgical options include chemonucleolysis, laminectomy, diskectomy, microdiskectomy, and spinal fusion.
  • Chemonucleolysis is the injection of an enzyme, such as chymopapain, into the disk to dissolve the protruding nucleus pulposus.
  • the enzyme is a protein-digesting enzyme and is used to dissolve the disk material. Since the enzyme is essentially a tissue-dissolving agent, it is indiscriminate in the protein-based matter it dissolves. Should the enzyme be injected into the wrong place, or if there is a breach in the disk capsule that would allow the solution to enter the spinal canal or to contact nerve tissue or the like, the resultant damage to nerve tissue could not be reversed. Even worse, about half of the patients who receive chemonucleolysis treatments experience increased back pain and muscle spasms immediately after the injection and more than half have incapacitating back pain for durations up to three months after such treatments.
  • a laminectomy is performed to decompress the spinal canal 108 by open surgical techniques under general anesthesia.
  • the lamina 110 (the bone that curves around and covers the spinal canal 108 as shown in Fig. 9 ), and any disk tissue causing pressure on a nerve or the spinal canal 108, are partially removed.
  • This technique is highly invasive and traumatic to the body, and therefore requires an extended recovery time of about five weeks and a hospital stay of a few days.
  • the vertebrae 100 may shift due to the lack of support in the structure.
  • simply removing the disk and parts of the vertebral bone is a short-term, pain-relieving corrective action but not a long-term solution.
  • Diskectomy is a form of spinal surgery wherein part of an intervertebral disk is excised typically through open surgical techniques. Recently, less invasive techniques referred to as percutaneous diskectomy or microdiskectomy have been developed to reduce the surgical trauma to the patient. In microdiskectomy, a much smaller incision is made than in normal open surgeries. A small retractor, working channel or tube is inserted through the posterior muscles (not shown) to allow access to the intervertebral space of a damaged or herniated disk.
  • Surgeons utilize special surgical instruments modified to work in such small openings such as curettes, osteotomes, reamers, probes, retractors, forceps, and the like to cut and remove part of the disk while monitoring their technique using a microscope, a fluoroscope (real-time X-ray monitoring), and/or an endoscope (a miniature TV camera with associated viewing monitor). While this technique is much less invasive than conventional open surgeries, due to their design the instruments presently available tend to extend the length of time of the surgery and may cause possible damage to areas other than the herniated disk.
  • a damaged disk may be completely removed.
  • Parts of a bone from another part of the body, such as the pelvis, are harvested, and the bone parts or grafts are subsequently placed between the adjacent vertebrae 100 so that the adjacent vertebrae 100 grow together in a solid mass.
  • the posterior lamina 110 and the centers of the vertebral bodies 106 may both be cut. The surgery often involves consequential damage to the associated posterior ligaments, muscles and joints in addition to the removal of part or all of the lamina 110.
  • the recovery time for a normal spinal fusion surgery is significant due not only to the fact that normal movement cannot be allowed until detectable bone growth has occurred between the bone grafts and the adjacent vertebrae 100, but the associated ligaments, muscles and the location where the bone grafts were harvested must also recover. Oftentimes portions of the spine 120 must be immobilized during the recovery period causing added discomfort and inconvenience to the patient.
  • nuclear replacements are generally designed with either a water retaining chemical in a compartment (bag-like container) or with various woven fiber or pad configurations using synthetic materials as a support cushion.
  • nuclear replacements have significant potential because the annulus and the endplates are substantially preserved, so long as they were not damaged by previous trauma.
  • the available nuclear replacements lack the strength of a human disk nucleus pulposus matter and/or the damage to the annulus during implantation may allow extrusion of the nuclear replacement not unlike a diskherniation.
  • the prior art devices for total disk replacements are generally made with opposing metal bodies and an interstitial polyethylene plastic body or the like.
  • the greatest difficulty to date has been designing a mechanical structure that closely matches that of the human intervertebral disk with regard to such properties as compression, flexion, extension, torsion and the like, not to mention in endurance/durability.
  • prior art intervertebral disk implants are typically as large as a human intervertebral disk so as to match the vertebrae 100 thereby distributing the compressive loads over a greater area, but necessitating extensive open surgery.
  • critical support materials such as the ligaments and endplate 110, are usually cut away during the surgical procedure leaving the newly implanted disk replacement with less stability.
  • US 5,674,296 relates to a spinal disc endoprosthesis comprising a central nucleus portion and an exterior annular gasket portion wherein concaval-convex elements at least partly surround the nucleus portion so as to retain the nucleus portion and gasket portion between adjacent vertebral bodies in a patient's spine.
  • US 4,349,921 refers to an intervertebral disc prosthesis having slightly convex superior and inferior surfaces, a flange or lip raised from said superior and inferior surfaces at one longitudinal end of the prosthesis, and a wedge shaped tapering portion at the other longitudinal end.
  • US 5,425,773 refers to a disk arthroplasty device formed with ball and socket members and shaped to provide lateral bending and backward extension.
  • the present invention comprises an intervertebral disk prosthesis in accordance with claim 1.
  • Fig.1 is a perspective view of a disk prosthesis in accordance with a first preferred embodiment of the present invention
  • Fig. 2 is a side elevational view of the disk prosthesis of Fig.1 ;
  • Fig. 3 is a front elevational view of the disk prosthesis of Fig.1 ;
  • Fig. 4 is a top plan view of the disk prosthesis of Fig.1 ;
  • Fig. 5 is a side sectional view of the disk prosthesis of Fig. 1 ;
  • Fig. 6A is a side sectional view of a second preferred embodiment of a disk prosthesis in accordance with the present invention.
  • Fig. 6B is a side sectional view of a third preferred embodiment of a disk prosthesis in accordance with the present invention.
  • Fig. 6C is a side sectional view of a fourth preferred embodiment of a disk prosthesis in accordance with the present invention.
  • Fig. 7A is a side elevational view of the disk prosthesis of Fig. 6A connected to a first insertion tool;
  • Fig. 7B is a side elevational view of the disk prosthesis of Fig. 6A connected to a second insertion tool;
  • Fig. 7C is a side elevational view of the disk prosthesis of Fig. 6A connected to a third insertion tool;
  • Fig. 8 is a side view of the lumbar section of a human spine with a disk prosthesis shown not to scale installed between vertebra L III and vertebra L IV ;
  • Fig. 9 is a top sectional view of a human vertebra as is known in the art.
  • Fig. 10 is a side sectional view of a portion of a human spine as is known in the art
  • Fig. 11A is a side elevational view of a fifth preferred embodiment of a disk prosthesis in accordance with the present invention.
  • Fig. 11B is a front elevational view of the disk prosthesis of Fig. 11A ;
  • Fig. 12A is a side elevational view of a sixth preferred embodiment of a disk prosthesis in accordance with the present invention.
  • Fig. 12B is a front elevational view of the disk prosthesis of Fig. 12A ;
  • Fig. 13A is a side elevational view of a seventh preferred embodiment of a disk prosthesis in accordance with the present invention.
  • Fig. 13B is a front elevational view of the disk prosthesis of Fig. 13A ;
  • Fig. 14A is a side elevational view of an eighth preferred embodiment of a disk prosthesis in accordance with the present invention.
  • Fig. 14B is a front elevational view of the disk prosthesis of Fig. 14A ;
  • Fig. 15A is a side elevational view of a fourth insertion tool for a disk prosthesis in accordance with the present invention.
  • Fig. 15B is a top plan view of the insertion tool of Fig. 15A ;
  • Fig. 16A is a side elevational view of a fifth insertion tool for a disk prosthesis in accordance with the present invention.
  • Fig. 16B is a top plan view of the insertion tool of Fig. 16A .
  • FIG. 1 an artificial disk or disk prosthesis 10 having a distal end 10a, a proximal end 10b, a lower wall 10c, an upper wall 10d, a first sidewall 10e and a second sidewall 10f ( Figs. 3, 4 ).
  • the disk prosthesis 10 includes a first part or a cap 13.
  • the cap 13 includes a top 13d, a bottom 13c having an opening 13f, an outer surface 13a, and with reference to Fig. 5 , an inner surface 13b and a socket 13e extending into an interior of the cap 13 from the opening 13f and defined by the inner surface 13b.
  • the outer surface 13a proximate the top 13d contacts a concave portion 100b of a first vertebra 100.
  • the disk prosthesis 10 further includes a second part or a base 11 including a top 11d, a bottom 11c, and an outer surface 11a.
  • the outer surface 11a proximate the bottom 11c contacts a concave portion 100a of a a second vertebra 100, and the outer surface of the base 11 proximate the top 11d of the base 11 cooperatively engages the inner surface 13b of the cap 13 thereby preferably allowing at least two-degrees of freedom of movement.
  • the cap 13 and the base 11 when inserted into an intervertebral space 121 the cap 13 and the base 11 function together as one overall device, i.e., the disk prosthesis 10.
  • the cap 13 and the base 11 are preferably not mechanically connected.
  • the cap 13 and the base 11 are connected by a flexible structure or element (not shown) or are totally encased in a pliable, bio-compatible slip-cover or pouch (not shown).
  • the inner surface 13b and a portion 11e of the outer surface 11a that contacts the inner surface 13b are preferably formed of or coated with a bio-compatible, smooth, low-friction material with high durability, such as ceramic, an alloy or the like.
  • the outer surface 13a of the cap 13 and a portion 11b of the outer surface 11a of the base 11 that is not covered by the cap 13 comprise an outer prosthesis surface 12 that is substantially smooth over the entire surface.
  • the structure of the prosthesis 10 is preferably a bio-compatible metal, a bio-compatible alloy or a bio-compatible ceramic.
  • the structure may be titanium, stainless steel, alloys such as a cobalt-chrome molybdenum alloy, polymeric materials, composites, and the like without departing from the broad inventive scope of the present invention.
  • the disk prosthesis 10 preferably is generally ovoid or egg-shaped and symmetrical along the longer axis with rounded or contoured edges on all sides.
  • the lower wall 10c and upper wall 10d preferably are generally convex in order to cooperatively mate with the natural concavity of adjacent vertebrae 100.
  • the first sidewall 10e and second sidewall 10f of the disk prosthesis 10 preferably are similarly convex for similar reasons and to facilitate installation of the disk prosthesis 10 into an intervertebral space 121.
  • the overall shape of the disk prosthesis is such that it can be inserted into an intervertebral space 121 using minimally invasive techniques through a special portal or channel allowing disk arthroplasty on an outpatient basis.
  • the proximal end 10b is rounded but more bluntly-shaped than the distal end 10a which is sloped into a bullet-shaped tip.
  • the lower wall 10c preferably includes a lower mesh structure 16a and the upper wall 10d of the disk prosthesis 10 preferably includes an upper mesh structure 16b at the point of vertebral contact to encourage successful vertebral bone ingrowth thereby affixing the cap 13 to a first or upper vertebra 100 and the base 11 to a second or lower vertebra 100 in an adjacent pair of vertebrae 100.
  • the lower mesh structure 16a and the upper mesh structure 16b may be a grid, a lattice, a plurality of perforations or apertures that extend partially through or completely through the outer surface 12, or any other configuration capable of allowing vertebral bone ingrowth.
  • the mesh structures 16a, 16b may or may not be symmetrically shaped.
  • the mesh structures 16a, 16b are preferably identically-shaped with respect to one another and are preferably symmetrically-shaped, but need not be. It is contemplated that the mesh structures 16a, 16b are each a larger aperture, or alternatively, are each a generally continuous section of a bio-compatible porous material such as hydroxyapatite coated metals or an irregular metal surface coated with hydroxyapatite coating. It is further contemplated that the mesh structures 16a, 16b are not flush with the edges of the outer surface 12, but are instead slightly below the edges of the outer surface 12 to allow for subsidence of the vertebrae and greater bone ingrowth.
  • the length of the disk prosthesis as measured from the distal end 10a to the proximal end 10b is approximately 10-30 mm, depending on the particular intervertebral space 121 in which the disk prosthesis 10 is to be inserted.
  • the intervertebral space between lumbar vertebra L III and lumbar vertebra L IV for an average male would accommodate a disk prosthesis 10 of a length between approximately 25-30 mm.
  • the length of the disk prosthesis 10 could vary from the aforementioned range without departing from the invention.
  • the width of the disk prosthesis 10 as measured between the first sidewall 10e and the second sidewall 10f of the disk prosthesis 10 will vary from approximately 10 mm to 25 mm depending upon the particular intervertebral space 121 in which the disk prosthesis 10 is to be inserted.
  • the intervertebral space between vertebra L III and vertebra L IV in an average male would accommodate a disk prosthesis 10 having a width of approximately 15-20 mm.
  • the width of the disk prosthesis 10 could vary from the aforementioned range without departing from the invention.
  • the height of the disk prosthesis 10 as measured between the upper wall 10d and the lower wall 10c of the disk prosthesis 10 will vary from approximately 5 mm to 25 mm depending upon the particular intervertebral space 121 in which the disk prosthesis 10 is to be inserted.
  • the intervertebral space between vertebra L III and vertebra L IV in an average male would accommodate a disk prosthesis 10 having a height of approximately 8-16 mm.
  • the height of the disk prosthesis 10 could vary from the aforementioned range without departing from the invention.
  • Fig. 5 shows a side sectional view of the disk prosthesis 10 as viewed from lines 5-5 of Fig. 4 .
  • Fig. 5 more clearly shows the cooperative interaction between the cap 13 and the base 11.
  • a portion 11e of the outer surface 11a of the base 11 proximate the top 11d of the base 11 cooperatively engages the inner surface 13b of the cap 13 thereby allowing at least two-degrees of freedom of movement.
  • Motion allowed includes rotation (roll) and tilting or angulation (pitch) in any direction, but not motion in the plane from front to back or side to side (i.e., parallel to the disk space).
  • the inner surface 13b and the portion 11e of the outer surface 11a that contacts the inner surface 13b are generally concealed.
  • the overall shape of the disk prosthesis 10 is designed for insertion using minimally invasive techniques through a special portal or channel allowing a replacement procedure to be implemented on an outpatient basis.
  • the convex and contoured shape of the disk prosthesis 10 will allow the disk prosthesis 10 to be driven into an intervertebral disk space 121 by merely temporarily distracting the vertebrae with minimal removal of the vertebral rim or annulus (not shown clearly) at the point of entry, thereby reducing the chance of dislodging the device post-surgery.
  • the smooth contour and edges of the disk prosthesis 10 provide for a safe and easy entrance into the intervertebral space 121.
  • the disk prosthesis 10 is a self centering device. Due largely to the shape of the disk prosthesis 10, the disk prosthesis 10 will tend to find the natural concavity of adjacent vertebrae 100. As such, placement of the disk prosthesis 10 is much faster than that of prior art intervertebral disk replacement devices, thereby effectively reducing the duration of an intervertebral disk replacement procedure and the associated risks therewith.
  • the self-centering feature of the disk prosthesis 10 will allow rapid settling of the disk prosthesis 10 into adjacent vertebral bone to promote rapid bone ingrowth while retention of most of the annulus and peripheral rim of the vertebrae 100 would provide good load sharing support to prevent excessive subsidence, where subsidence is the natural settling of intervertebral matter into a softer central portion of the vertebral bodies 106.
  • Figure 8 shows a side view of the lumbar region 122 of a portion of a human spine 120.
  • the disk prosthesis 10 in accordance with the first preferred embodiment of the present invention is shown installed between lumbar vertebra L III and lumbar vertebra L IV .
  • the second sidewall 10f of the disk prosthesis 10 is placed on the anterior side of the L III - L IV intervertebral space
  • the first sidewall 10e of the disk prosthesis 10 is placed closest to the posterior side of the L III - L IV intervertebral space
  • the upper wall 10d of the disk prosthesis 10 is adjacent to vertebra L III
  • the lower wall 10c of the disk prosthesis 10 is adjacent to vertebra L IV .
  • the surgeon would have inserted the distal end 10a of the disk prosthesis 10 into the gap between the L III - L IV vertebrae as depicted in Fig. 9 by a directional arrow D. It is just as likely and possible for the surgeon to place the distal end 10a of the disk prosthesis 10 through the space between the L III - L IV vertebrae in the direction of a directional arrow C ( Fig. 9 ) or from any other direction.
  • Fig. 6A shows a side sectional view of a second preferred embodiment of a disk prosthesis 60 in accordance with the present invention.
  • the disk prosthesis 60 has a distal end 60a, a proximal end 60b, a lower wall 60c, an upper wall 60d, a first sidewall 60e ( Figs. 7A-7C ), and a second sidewall (not shown).
  • the disk prosthesis includes a first part or a cap 63.
  • the cap 63 includes a top 63d, a bottom 63c having an opening 63f, an outer surface 63a, an inner surface 63b and a socket 63e extending into an interior of the cap 63 from the opening and defined by the inner surface 63b.
  • the outer surface 63a proximate the top 63d contacts a concave portion 100b of a first vertebra 100.
  • the disk prosthesis 60 further includes a second part or a base 61 including a top 61d, a bottom 61c, and an outer surface 61a.
  • the outer surface 61a proximate the bottom 61c contacts a concave portion 100a of a second vertebra 100, and the outer surface 61a of the base 61 proximate the top 61d of the base 61 cooperatively engages the inner surface 63b of the cap 63 thereby allowing at least two-degrees of freedom of movement.
  • the cap 63 and the base 61 When inserted into an intervertebral space 121 the cap 63 and the base 61 function together as one overall device, i.e., the disk prosthesis 60.
  • the cap 63 and the base 61 are preferably not mechanically connected.
  • the base 61 is preferably not retained in the cap 63, but could be.
  • the cap 63 and the base 61 are connected by a flexible structure or element (not shown) or are totally encased in a pliable, bio-compatible slip-cover or pouch (not shown).
  • the inner surface 63b and a portion 61e of the outer surface 61 a that contacts the inner surface 63b are preferably formed of or coated with a bio-compatible, smooth, low-friction material with high durability, such as a ceramic, an alloy or the like.
  • the top 61d of the base 61 includes a spherically or hemispherically-shaped portion or a ball 61f.
  • the ball 61f of the base 61 cooperatively engages the socket 63e of the cap 63 thereby mimicking a ball and socket joint such as a hip-joint.
  • the lower wall 60c includes a lower mesh structure 66a and the upper wall 60d of the disk prosthesis 60 includes an upper mesh structure 66b at the point of vertebral contact to encourage successful vertebral bone ingrowth thereby affixing the cap 63 to a first or upper vertebra 100 and the base 61 to a second or lower vertebra 100 in an adjacent pair of vertebrae 100.
  • the lower mesh 66a and the upper mesh 66b may have the attributes of the lower mesh 16a and the upper mesh 16b discussed above with reference to the first preferred embodiment.
  • Fig. 6B shows a side sectional view of a third preferred embodiment of a disk prosthesis 70 in accordance with the present invention.
  • the disk prosthesis 70 has a distal end 70a, a proximal end 70b, a lower wall 70c, an upper wall 70d, a first sidewall (not shown), and a second sidewall (not shown).
  • the disk prosthesis includes a first part or a cap 73.
  • the cap 73 includes a top73d, a bottom 73c having an opening 73f, an outer surface 73a, an inner surface 73b and a socket 73e extending into an interior of the cap 73 from the opening and defined by the inner surface 73b.
  • the outer surface 73a proximate the top 73d contacts a concave portion 100b of a first vertebra 100.
  • the disk prosthesis 70 further includes a second part or a base 71 including a top 71d, a bottom 71c, and an outer surface 71a.
  • the outer surface 71a proximate the bottom 71c contacts a concave portion 100a of a second vertebra 100, and the outer surface 71a of the base 71 proximate the top 71d of the base 71 cooperatively engages the inner surface 73b of the cap 73 thereby allowing at least two-degrees of freedom of movement.
  • the cap 73 and the base 71 When inserted into an intervertebral space 121 the cap 73 and the base 71 function together as one overall device, i.e., the disk prosthesis 70.
  • the cap 73 and the base 71 are preferably not mechanically connected.
  • the base 71 is preferably not retained in the cap 73, but could be.
  • the cap 73 and the base 71 are connected by a flexible structure or element (not shown) or are totally encased in a pliable, bio-compatible slip-cover or pouch (not shown).
  • the inner surface 73b and a portion 71e of the outer surface 71a that contacts the inner surface 73b are preferably formed of or coated with a bio-compatible, smooth, low-friction material with high durability, such as a ceramic, an alloy or the like.
  • the top 71d of the base 71 includes a spherically or hemispherically-shaped portion or a ball 71f.
  • the ball 71f of the base 71 cooperatively engages the socket 73e of the cap 73 thereby mimicking a ball and shallow socket joint such as a shoulder-joint.
  • the lower wall 70c includes a lower mesh structure 76a and the upper wall 70d of the disk prosthesis 70 includes an upper mesh structure 76b at the point of vertebral contact to encourage successful vertebral bone ingrowth thereby affixing the cap 73 to a first or upper vertebra 100 and the base 71 to a second or lower vertebra 100 in an adjacent pair of vertebrae 100.
  • the lower mesh 76a and the upper mesh 76b may have the attributes of the lower mesh 16a and the upper mesh 16b discussed above with reference to the first preferred embodiment.
  • Fig. 6C shows a side sectional view of a fourth preferred embodiment of a disk prosthesis 80 in accordance with the present invention.
  • the disk prosthesis 80 has a distal end 80a, a proximal end 80b, a lower wall 80c, an upper wall 80d, a first sidewall (not shown), and a second sidewall (not shown).
  • the disk prosthesis includes a first part or a cap 83.
  • the cap 83 includes a top 83d, a bottom 83c having an opening 83f, an outer surface 83a, an inner surface 83b and a socket 83e extending into an interior of the cap 83 from the opening and defined by the inner surface 83b.
  • the outer surface 83a proximate the top 83d contacts a concave portion 100b of a first vertebra 100.
  • the disk prosthesis 80 further includes a second part or a base 81 including a top 81 d, a bottom 81c, and an outer surface 81 a.
  • the outer surface 81a proximate the bottom 81c contacts a concave portion 100a of a second vertebra 100, and the outer surface 81a of the base 81 proximate the top 81 d of the base 81 cooperatively engages the inner surface 83b of the cap 83 thereby allowing at least two-degrees of freedom of movement.
  • the cap 83 and the base 81 When inserted into an intervertebral space 121 the cap 83 and the base 81 function together as one overall device, i.e., the disk prosthesis 80.
  • the cap 83 and the base 81 are preferably not mechanically connected.
  • the base 81 is preferably not retained in the cap 83, but could be.
  • the cap 83 and the base 81 are connected by a flexible structure or element (not shown) or are totally encased in a pliable, bio-compatible slip-cover or pouch (not shown).
  • the inner surface 83b and a portion 81e of the outer surface 81a that contacts the inner surface 83b are preferably formed of or coated with a bio-compatible, smooth, low-friction material with high durability, such as a ceramic, an alloy or the like.
  • the top 81d of the base 81 includes a spherically or hemispherically-shaped portion or a ball 81f.
  • the ball 81f of the base 81 cooperatively engages the socket 83e of the cap 83 thereby mimicking a ball and shallow socket joint such as a shoulder-joint.
  • the lower wall 80c includes a lower mesh structure 86a and the upper wall 80d of the disk prosthesis 80 includes an upper mesh structure 86b at the point of vertebral contact to encourage successful vertebral bone ingrowth thereby affixing the cap 83 to a first or upper vertebra 100 and the base 81 to a second or lower vertebra 100 in an adjacent pair of vertebrae 100.
  • the lower mesh 86a and the upper mesh 86b may have the attributes of the lower mesh 16a and the upper mesh 16b discussed above with reference to the first preferred embodiment.
  • Fig. 7A shows the disk prosthesis 60 of the second preferred embodiment with a specially designed first insertion tool 18 having a handle 18a and a plurality of resilient grasping fingers 19.
  • the grasping fingers 19 are actuated to grasp and hold the disk prosthesis 60 by moving a tool actuation stem 17 proximally and to open and release the disk prosthesis 60 by moving the tool actuation stem 17 distally.
  • the handle 18a of the first insertion tool 18 may be formed of any substantially rigid material, but preferably is formed of a material that is bio-compatible such as titanium, stainless steel, or of a bio-compatible alloy, composite, polymeric material or the like.
  • the grasping fingers 19 are preferably formed of a resilient, bio-compatible synthetic or polymeric material. It is contemplated that the grasping fingers 19 are biased by either their own resiliency or by other resilient means (not shown) such as coil springs in order to allow the grasping fingers 19 to grasp the disk prosthesis 60 without actuation but to be capable of releasing the disk prosthesis by merely twisting or moving the first insertion tool 18 proximally at a slight angle.
  • Fig. 7B shows the disk prosthesis 60 of the second preferred embodiment with a specially designed second insertion tool 22 having a handle 22a and a suction cup 23.
  • the handle 22a of the second insertion tool 22 may be formed of any substantially rigid material, but preferably is formed of a material that is bio-compatible such as titanium, stainless steel, or of a bio-compatible alloy, composite, polymeric material or the like. It should be noted that the material of construction of the handle 22a of the second insertion tool 22 could be any material without diverging from the broad scope of the present invention.
  • the suction cup 23 is preferably formed of a resilient, bio-compatible synthetic or polymeric material.
  • the suction cup 23 is biased inwardly by its own resiliency in order to allow the suction cup 23 to grasp the disk prosthesis 60 without actuation but to be capable of releasing the disk prosthesis by merely twisting or moving the second insertion tool 22 proximally at a slight angle.
  • Fig. 7C shows the disk prosthesis 60 of the second preferred embodiment with a specially designed third insertion tool 20 having a handle 20a and being threaded into a socket 64 with female threads 64a by male threads 20b of the third insertion tool 20.
  • the handle 20a of the third insertion tool 20 may be formed of any substantially rigid material, but preferably is formed of a material that is bio-compatible such as titanium, stainless steel, or of a bio-compatible alloy, composite, polymeric material or the like. It should be noted that the material of construction of the third insertion tool 20 could be any material without diverging from the broad scope of the present invention. Design of insertion tools are not critical to the present invention, and a variety of tool designs are contemplated for use with various disk prostheses.
  • Figs. 11A-11B show a fifth preferred embodiment of a disk prosthesis in accordance with the present invention.
  • the disk prosthesis 90 has a distal end 90a, a proximal end 90b, a lower wall 90c, an upper wall 90d, a first sidewall (not shown), and a second sidewall (not shown).
  • the disk prosthesis includes a first part or a cap 93.
  • the cap 93 includes a top 93d, a bottom 93c having an opening 93f, an outer surface 93a, an inner surface 93b and a socket 93e extending into an interior of the cap 93 from the opening and defined by the inner surface 93b.
  • the outer surface 93a proximate the top 93d contacts a concave portion 100b of a first vertebra 100.
  • the disk prosthesis 90 further includes a second part or a base 91 including a top 91d, a bottom 91 c, and an outer surface 91 a.
  • the outer surface 91 a proximate the bottom 91c contacts a concave portion 100a of a second vertebra 100, and the outer surface 91 a of the base 91 proximate the top 91 d of the base 91 cooperatively engages the inner surface 93b of the cap 93 thereby allowing at least two-degrees of freedom of movement.
  • the cap 93 is preferably slightly smaller than the base 91 in both length and width in order to allow freedom movement even when bone growth reaches near the edges of the cap 93 and/or base 91.
  • the base 91 may be slightly smaller than the cap 93 for similar reasons without departing from the present invention.
  • the disk prosthesis 90 includes at least one upper arch 150 and at least one lower arch 152, but preferably the disk prosthesis 90 includes three upper arches 150 and three lower arches 152.
  • the arches 150, 152 are generally disposed symmetrically along and about a centerline of the longer axis of the disk prosthesis 90 and are secured to the body of the disk prosthesis 90.
  • the arches 150, 152 may be secured to the disk prosthesis 90 by other means and may be disposed in other orientations without departing from the present invention.
  • the arches 150, 152 protrude above the top and bottom 190d, 190c of the disk prosthesis 90, respectively.
  • the arches 150, 152 are configured to settle into bone matter, and therefore, the arches 150, 152 have sharpened edges 150a, 152a.
  • the sharpened edges 150a, 152a may include serrations, pins, sharpened cones or a simple knife-like edge, but need not be.
  • the sharpened edges 150a, 152a are partially knife like proximate the ends of the arches and partially covered with sharpened cones 153.
  • the arches 150, 152 are preferably about 0.5 mm to about 2.0 mm wide.
  • the arches 150, 152 also serve to center the disk prosthesis 90 during placement and prevent the disk prosthesis 90 from rolling or canting thereafter.
  • Figs. 12A-12B show a sixth preferred embodiment of a disk prosthesis 190 in accordance with the present invention.
  • the disk prosthesis 190 has a distal end 190a, a proximal end 190b, a lower wall 190c, an upper wall 190d, a first sidewall 190e, and a second sidewall 190f.
  • the disk prosthesis includes a first part or a cap 193.
  • the cap 193 includes a top 193d, a bottom 193c having an opening 193f, an outer surface 193a, an inner surface (not shown) and a socket (not shown) extending into an interior of the cap 193 from the opening and defined by the inner surface.
  • the outer surface 193a proximate the top 193d contacts a concave portion 100b of a first vertebra 100.
  • the disk prosthesis 190 further includes a second part or a base 191 including a top 191d, a bottom 191c, and an outer surface 191a.
  • the outer surface 191a proximate the bottom 191c contacts a concave portion 100a of a second vertebra 100, and the outer surface 191a of the base 191 proximate the top 191d of the base 191 cooperatively engages the inner surface (not shown) of the cap 193 thereby allowing at least two-degrees of freedom of movement.
  • the disk prosthesis 190 includes at least one upper arch 150 and at least one lower arch 152, but preferably the disk prosthesis 190 includes three upper arches 150 and three lower arches 152 similar to the disk prosthesis 90.
  • the arches 150, 152 are generally disposed symmetrically along and about a centerline of the longer axis of the disk prosthesis 190 and are secured to the body of the disk prosthesis 190.
  • the top of the cap 193 has a recess and the bottom of the base 191 has a recess, the recesses include a platform 193h and 191h, respectively.
  • the platforms 191h, 193h are preferably are texturized and/or coated with a material to promote bone growth.
  • Figs. 13A-13B show a seventh preferred embodiment of a disk prosthesis 290 in accordance with the present invention.
  • the disk prosthesis 290 has a distal end 290a, a proximal end 290b, a lower wall 290c, an upper wall 290d, a first sidewall 290e, and a second sidewall 290f.
  • the disk prosthesis includes a first part or a cap 293.
  • the cap 293 includes a top 293d, a bottom 293c having an opening 293f, an outer surface 293a, an inner surface (not shown) and a socket (not shown) extending into an interior of the cap 293 from the opening and defined by the inner surface.
  • the outer surface 293a proximate the top 293d contacts a concave portion 100b of a first vertebra 100.
  • the disk prosthesis 290 further includes a second part or a base 291 including a top 291d, a bottom 291c, and an outer surface 291a.
  • the outer surface 291a proximate the bottom 291c contacts a concave portion 100a of a second vertebra 100, and the outer surface 291 a of the base 291 proximate the top 291d of the base 291 cooperatively engages the inner surface (not shown) of the cap 293 thereby allowing at least two-degrees of freedom of movement.
  • the disk prosthesis 290 includes at least one upper arch 150 and at least one lower arch 152, but preferably the disk prosthesis 290 includes three upper arches 150 and three lower arches 152 similar to the disk prosthesis 90.
  • the arches 150, 152 are generally disposed symmetrically along and about a centerline of the longer axis of the disk prosthesis 290 and are secured to the body of the disk prosthesis 290.
  • the top of the cap 293 and the bottom of the base 291 are preferably flatly shaped.
  • the flat surfaces preferably are texturized and/or coated with a material to promote bone growth.
  • Figs. 14A-14B show an eighth preferred embodiment of a disk prosthesis 390 in accordance with the present invention.
  • the disk prosthesis 390 has a distal end 390a, a proximal end 390b, a lower wall 390c, an upper wall 390d, a first sidewall 390e, and a second sidewall 390f.
  • the disk prosthesis includes a first part or a cap 393.
  • the cap 393 includes a top 393d, a bottom 393c, an outer surface 393a, an inner surface (not shown) and a socket (not shown) extending into an interior of the cap 393 from the opening and defined by the inner surface 393b.
  • the outer surface 393a proximate the top 393d contacts a concave portion 100b of a first vertebra 100.
  • the disk prosthesis 390 further includes a second part or a base 391 including a top 391 d, a bottom 391c, and an outer surface 391a.
  • the outer surface 391a proximate the bottom 391c contacts a concave portion 100a of a second vertebra 100, and the outer surface 391 a of the base 391 proximate the top 391d of the base 391 cooperatively engages the inner surface (not shown) of the cap 393 thereby allowing at least two-degrees of freedom of movement.
  • the disk prosthesis 390 includes at least one row of sharpened cones 153 on the top of the cap 393 and at least one row of sharpened cones 153 on the bottom of the base 391, but preferably the disk prosthesis 390 includes three rows of sharpened cones 153 on the top of the cap 393 and three rows of sharpened cones 153 on the bottom of the base 391.
  • the rows of sharpened cones 153 are generally disposed symmetrically along and about a centerline of the longer axis of the disk prosthesis 390 and are secured to the body of the disk prosthesis 390.
  • the top of the cap 393 and the bottom of the base 391 are preferably convexly shaped to more readily find the contours of the concave portions 100a, 100b of adjacent vertebrae 100.
  • the surface of the disk prosthesis 390 proximate the rows of sharpened cones 153 is texturized and/or coated with a material to promote bone growth such as hydroxyapatite.
  • Figs. 15A-15B show a fourth insertion tool 220 for a disk prosthesis 10 (60, 70, or 80) having lower and upper openings 16a, 16b (66a, 66b, 76a, 76b, 86a, 86b), respectively.
  • the insertion tool 220 has a first finger 224 configured to cooperatively engage the lower opening 16a and a second finger 222 configured to cooperatively engage the upper opening 16b.
  • the fingers 222, 224 have outer surfaces which are shaped to match the contoured shape of the disk prosthesis 10 to allow a smooth insertion of the disk prosthesis 10.
  • the fingers 222, 224 also prevent foreign matter and debris from getting caught in the openings 16a, 16b during insertion. Because the fingers 222, 224 grasp the disk prosthesis 10 in a specific orientation defined by the upper and lower openings 16a, 16b, the insertion tool 220 provides the surgeon with means to orient the disk prosthesis 10 correctly during insertion.
  • the insertion tool 220 further includes a driving member 226 that is configured to engage the body of the disk prosthesis 10.
  • the driving member 226 is configured to be impacted such that during insertion a surgeon may tap or hammer the driving member 226 to push the disk prosthesis 10 through a small opening.
  • the first and second fingers 222, 224 are retractable relative to the driving member 226.
  • the disk prosthesis 10 may have grooves 166 (shown in phantom in Fig.
  • the insertion tool 220 includes third and fourth fingers 228 (shown in phantom in Fig. 15A-15B ) configured to retractably move along the space between the upper part 13 and the lower part 11 of the body of the disk prosthesis 10.
  • Figs. 16A-16B is a side elevational view of a fifth insertion tool 230 for a disk prosthesis 90 (190, 290 or 390) having upper and lower openings 96a, 96b and upper and lower arches 150, 152.
  • the upper finger 232 has first and second prongs 232a, 232b for straddling the upper arches 150 as best seen in Fig. 16B .
  • the insertion tool 230 is similar to the insertion tool 220, but each of the retractable fingers 232, 234 is forked to accommodate the arches 150, 152.
  • the arches 150, 152 and the rows of cones 153 are just below the outer surface of the fingers 232, 234, so that the arches 150, 152 do not injure adjacent tissue during insertion.
  • the insertion tool 230 includes third and fourth fingers 238 (shown in phantom in Fig. 16A-16B ) configured to retractably move between the space between the upper part 93 and the lower part 91 of the body of the disk prosthesis 90.
  • the intervertebral disk prostheses 10, 60, 70, 90, 190, 290 and 390 have a freedom of movement that is limited to between about 2-15 degrees tilt in any direction.
  • the annular ligament of a human being is built for physiologic limiting thereby stopping over rotation.
  • the facets in the lumbar region also limit rotation and tilt.

Claims (27)

  1. Bandscheibenprothese (10, 60, 70, 90, 190, 290, 390), umfassend:
    ein konvex verjüngtes distales Ende (..Oa), ein proximales Ende (..Ob),
    eine erste Seitenwand (..Oe) und eine zweite Seitenwand (..Of);
    einen oberen Teil (..3) mit einem konvex geformten und gerundeten oberen Ende (..3d), einen Boden (..3c) mit einer Öffnung (..3f), eine Außenfläche (..3a), eine Innenfläche (..3b) und eine Pfanne (..3b), die sich von der Öffnung (..3f) in den oberen Teil (..3) hinein erstreckt, wobei die Außenfläche (..3a) in der Nähe des oberen Endes (..3d) für den Kontakt mit einem konkaven Bereich eines ersten Wirbels ausgebildet ist; und
    einen unteren Teil (..1) mit einem oberen Ende (..1d), einen konvex geformten und gerundeten Boden (..1 c) und eine Außenfläche (..1 a),
    wobei die Außenfläche in der Nähe des Bodens für den Kontakt mit einem konkaven Bereich eines dem ersten Wirbel benachbarten zweiten Wirbels ausgebildet ist und wobei die Außenfläche des unteren Teils in der Nähe des oberen Endes des unteren Teils (..1 d) zusammenwirkend und beweglich von der Innenfläche (..3b) des oberen Teils (..3) überdeckt wird und dadurch eine Bewegungsfreiheit von zumindest zwei Grad ermöglicht,
    und wobei die erste und die zweite Seitenwand (..Oe, ..Of) zumindest teilweise konvex geformt sind, um das Einsetzen der Bandscheibenprothese in einen durch die Konkavität der benachbarten ersten und zweiten Wirbel zu ermöglichen,
    dadurch gekennzeichnet, dass das proximale Ende konvex verjüngt und gerundet ist, jedoch stumpfer ist als das distale Ende, das zu einer geschossförmigen Spitze abfällt, wobei die Bandscheibenprothese aufgrund ihrer Form so beschaffen ist, dass sie eine selbstzentrierende Vorrichtung bildet.
  2. Bandscheibenprothese nach Anspruch 1, wobei das obere Ende des oberen Teils eine Einwachsöffnung hat, um das Einwachsen des Wirbels zu fördern, und derart konfiguriert ist, dass die Bandscheibenprothese in einem Wirbelzwischenraum ausgerichtet wird.
  3. Bandscheibenprothese nach Anspruch 1 oder 2, wobei der Boden des unteren Teils eine Einwachsöffnung hat, um das Einwachsen der Wirbels zu fördern, und derart konfiguriert ist, dass die Bandscheibenprothese in einem Wirbelzwischenraum ausgerichtet wird.
  4. Bandscheibenprothese nach Anspruch 2 oder 3, ferner umfassend eine allgemein durchgehende Platte aus biokompatiblem porösem Material, die die Einwachsfläche zumindest teilweise überspannt.
  5. Bandscheibenprothese nach Anspruch 4, wobei das poröse Material ein hydroxylapatit-beschichtetes Metall ist.
  6. Bandscheibenprothese nach einem der Ansprüche 2 bis 5, ferner umfassend eine Netzstruktur, die die Einwachsfläche zumindest teilweise überspannt.
  7. Bandscheibenprothese nach einem der Ansprüche 2 bis 6, wobei der untere Teil ferner zumindest einen Bogen aufweist, der die Einwachsfläche überspannt.
  8. Bandscheibenprothese nach einem der Ansprüche 1 bis 7, wobei das distale Ende der Intervertebralprothese allgemein stumpf gerundet ist.
  9. Bandscheibenprothese nach einem der Ansprüche 1 bis 8, wobei das proximale Ende der Intervertebralprothese allgemein stumpf gerundet ist.
  10. Bandscheibenprothese nach einem der Ansprüche 1 bis 9, wobei eine Außenfläche der Intervertebralprothese allgemein gerundet ist.
  11. Bandscheibenprothese nach einem der Ansprüche 1 bis 10, wobei die Intervertebralprothese zumindest teilweise aus einem biokompatiblem Material gebildet ist, das aus der aus rostfreiem Stahl, Titan, Kobalt-Chrom-Legierung, vernickeltem Metall, einer biokompatiblen Legierung, einer biokompatiblen Keramik und einem biokompatiblen Polymermaterial bestehenden Gruppe ausgewählt ist.
  12. Bandscheibenprothese nach einem der Ansprüche 1 bis 11, ferner umfassend eine biegsame Schutzhülle, die zumindest einen Bereich des oberen Teils und einen Bereich des unteren Teils verhüllt, wobei die Schutzhülle derart konfiguriert ist, dass die die beweglich verbundenen oberen und unteren Teile flexibel festhält.
  13. Bandscheibenprothese nach einem der Ansprüche 1 bis 12, wobei die Länge der Intervertebralprothese gemessen von dem distalen Ende zu dem proximalen Ende zwischen ca. 10 mm und ca. 30 mm beträgt.
  14. Bandscheibenprothese nach einem der Ansprüche 1 bis 13, wobei die Breite der Intervertebralprothese gemessen zwischen der ersten Seitenwand und der zweiten Seitenwand zwischen ca. 10 mm und ca. 25 mm beträgt.
  15. Bandscheibenprothese nach einem der Ansprüche 1 bis 14, wobei die Höhe der Intervertebralprothese gemessen zwischen dem oberen Ende des oberen Teils und dem Boden des unteren Teils zwischen ca. 5 mm und ca. 25 mm beträgt.
  16. Bandscheibenprothese nach einem der Ansprüche 1 bis 15, wobei die Bewegungsfreiheit in jeder Richtung auf eine Neigung zwischen 2 bis 15 Grad beschränkt ist.
  17. Bandscheibenprothese nach einem der Ansprüche 1 bis 16, wobei die Scheibenprothese eine Translationsbewegung minimiert.
  18. Bandscheibenprothese nach einem der Ansprüche 1 bis 17, wobei von dem oberen Teil und dem unteren Teil zumindest einer einen an ihm angeordneten zugespitzten Kegel aufweist, der derart konfiguriert ist, dass er in dem Wirbelknochen versenkt wird.
  19. Bandscheibenprothese nach einem der Ansprüche 1 bis 18, wobei von dem oberen Teil und dem unteren Teil zumindest einer einen Bogen aufweist, der eine teilweise geschärfte Kante hat.
  20. Bandscheibenprothese nach einem der Ansprüche 1 bis 19, in Kombination mit einem Einsatzwerkzeug, das einen ersten Finger zum Ansetzen an einer Einwachsöffnung in dem oberen Ende des oberen Teils, einen zweiten Finger zum Ansetzen an einer Einwachsöffnung in dem Boden des unteren Teils und ein zwischen dem ersten und dem zweiten Finger angeordnetes Antriebselement hat.
  21. Kombination nach Anspruch 20, wobei das Antriebselement zum Ansetzen an der Intervertebralprothese ausgebildet ist.
  22. Kombination nach Anspruch 20 oder 21, wobei der erste und der zweite Finger einziehbar sind.
  23. Kombination nach Anspruch 22, wobei, wenn der erste und der zweite Finger mit den Einwachsöffnungen in Eingriff gebracht werden, alle exponierten Flächen der Kombination allgemein rund sind.
  24. Kombination nach einem der Ansprüche 20 bis 23, ferner umfassend dritte und vierte Finger, die für eine rückziehbare Bewegung in Zwischenraum zwischen dem oberen Teil und dem unteren Teil der Intervertebralprothese ausgebildet sind.
  25. Bandscheibenprothese nach einem der Ansprüche 1 bis 19, ferner umfassend einen Verbinder, der für die zeitweilige und lösbare Verbindung mit einem Einsatzwerkzeug ausgebildet ist.
  26. Bandscheibenprothese nach Anspruch 25, wobei der Verbinder entweder ein Gewindeschaft, eine Fassung, eine Rastung, ein Loch oder ein Schlitz ist.
  27. Bandscheibenprothese, umfassend:
    ein konvex verjüngtes distales Ende, ein proximales Ende, eine ersten Seitenwand (10e) und eine zweite Seitenwand (10f);
    einen unteren Teil mit einem konvex geformten und gerundeten Boden,
    einem oberen Ende mit einer Öffnung, einer Außenfläche, einer Innenfläche und einer Pfanne, die sich von der Öffnung nach innen in den unteren Teil hinein erstreckt, wobei die Außenfläche in der Nähe des Bodens für den Kontakt mit einem konkaven Bereich eines ersten Wirbels ausgebildet ist;
    einen oberen Teil mit einem Boden, einem konvex geformten und gerundeten oberen Ende und einer Außenfläche, wobei die Außenfläche in der Nähe des oberen Endes für den Kontakt mit einem konkaven Bereich eines dem ersten Wirbel benachbarten zweiten Wirbels ausgebildet ist und die Außenfläche des oberen Teils in der Nähe des Bodens zusammenwirkend und beweglich von der Innenfläche des unteren Teils überdeckt ist und dadurch eine Bewegungsfreiheit von mindestens zwei Grad ermöglicht; und
    wobei die erste und die zweite Seitenwand (10e, 10f) zumindest teilweise konvex geformt sind, um das Einsetzen der Bandscheibenprothese in einen durch die Konkavität der benachbarten ersten und zweiten Wirbel definierten Raum zu ermöglichen,
    dadurch gekennzeichnet, dass das proximale Ende konvex verjüngt und gerundet ist, jedoch stumpfer ausgebildet ist als das distale Ende, das zu einer geschossförmigen Spitze abfällt, wobei die Bandscheibenprothese aufgrund ihrer Form so beschaffen ist, dass sie eine selbstzentrierende Vorrichtung bildet.
EP03731993A 2002-01-17 2003-01-17 Bandscheibenprothese Expired - Lifetime EP1471855B1 (de)

Applications Claiming Priority (5)

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US34974302P 2002-01-17 2002-01-17
US349743P 2002-01-17
US36966702P 2002-04-02 2002-04-02
US369667P 2002-04-02
PCT/US2003/001597 WO2003061364A2 (en) 2002-01-17 2003-01-17 Intervertebral disk prosthesis

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EP1471855A2 EP1471855A2 (de) 2004-11-03
EP1471855A4 EP1471855A4 (de) 2007-01-03
EP1471855B1 true EP1471855B1 (de) 2010-12-29

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US (3) US7011684B2 (de)
EP (1) EP1471855B1 (de)
JP (1) JP2005515002A (de)
AT (1) ATE493093T1 (de)
AU (1) AU2003210569A1 (de)
DE (1) DE60335519D1 (de)
WO (1) WO2003061364A2 (de)

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EP1471855A4 (de) 2007-01-03
WO2003061364A3 (en) 2003-11-13
AU2003210569A1 (en) 2003-09-02
US20060155378A1 (en) 2006-07-13
WO2003061364A2 (en) 2003-07-31
ATE493093T1 (de) 2011-01-15
DE60335519D1 (de) 2011-02-10
US7011684B2 (en) 2006-03-14
JP2005515002A (ja) 2005-05-26
EP1471855A2 (de) 2004-11-03
US20050043798A1 (en) 2005-02-24
US20030135278A1 (en) 2003-07-17

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